Atorvastatin Krka 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atorvastatina Krka 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Atorvastatina Krka is and what it is used for
2. What you need to know before taking Atorvastatina Krka
3. How to take Atorvastatina Krka
4. Possible side effects
5. How to store Atorvastatina Krka
6. Contents of the pack and other information

1. What Atorvastatine Krka is and what it is used for

Atorvastatine Krka belongs to a group of medicines known as statins, which are
lipid-regulating (fat-regulating) medicines.

Atorvastatine Krka is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, Atorvastatine Krka may also be used to reduce this risk, even if your cholesterol levels are normal. A standard low-cholesterol diet should be followed during treatment.

2. What you need to know before taking Atorvastatina Krka

Do not take Atorvastatina Krka

• if you are allergic to atorvastatin or to any of the other ingredients of this medicine (listed in section 6)

• if you have or have had any liver disease

• if you have or have had unexplained abnormal results in blood tests for liver function

• if you are a woman of childbearing age and are not using adequate contraceptive measures

• if you are pregnant or trying to become pregnant

• if you are breastfeeding

• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Atorvastatina Krka.

For the following reasons, Atorvastatina Krka may not be suitable for you:

• if you have severe respiratory failure

• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and atorvastatin may cause serious muscle problems (rhabdomyolysis)

• if you have previously had a stroke with bleeding in the brain, or have small fluid-filled sacs in the brain due to previous strokes

• if you have kidney problems

• if you have an underactive thyroid gland (hypothyroidism)

• if you have repeated or unexplained muscle pain, or personal or family history of muscle disorders

• if you have previously had muscle problems during treatment with other lipid-lowering medicines (e.g., with another statin or fibrates)

• if you regularly drink large amounts of alcohol

• if you have a history of liver problems

• if you are over 70 years old

• if you have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing), or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

In any of these cases, your doctor may decide whether you need blood tests before and possibly during treatment with Atorvastatina Krka to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g., rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Other medicines and Atorvastatina Krka”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

While taking this medicine, your doctor will monitor you for diabetes or risk factors for developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Other medicines and Atorvastatina Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may affect how Atorvastatina Krka works, or the effects of those medicines may be altered by Atorvastatina Krka. This type of interaction may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including serious muscle damage known as rhabdomyolysis described in section 4:

• Medicines used to modify the function of your immune system, for example, cyclosporine
• Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid
• Other medicines to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol
• Some calcium channel blockers used to treat angina or high blood pressure, for example, amlodipine, diltiazem
• Medicines to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone
• Letermovir, a medicine that helps prevent disease caused by cytomegalovirus
• Medicines used in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, combinations of tipranavir/ritonavir, etc.
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medicines known to interact with Atorvastatina Krka include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium)
• Over-the-counter medicines: St. John’s wort
• If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will advise you when you can restart treatment with Atorvastatina Krka. Using Atorvastatina Krka with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections)

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicines, including those obtained without a prescription.

Taking Atorvastatina Krka with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatina Krka. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice may alter the effects of Atorvastatina Krka.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding

Do not take Atorvastatina Krka if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Do not take Atorvastatina Krka if you are of childbearing age unless you are using adequate contraceptive measures.

Do not take Atorvastatina Krka if you are breastfeeding.

The safety of Atorvastatina Krka during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Normally, this medicine does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to drive. Do not operate tools or machines if your ability to operate them is affected by this medicine.

Atorvastatina Krka contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

3. How to take Atorvastatin Krka

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you must continue to follow during treatment with Atorvastatin Krka.

The usual starting dose of Atorvastatin Krka is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose you require.

Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatin Krka is 80 mg once daily.

Atorvastatin Krka tablets should be swallowed whole with a glass of water and may be taken at any time of day, with or without food. However, try to take your tablet at the same time each day.

Always follow exactly the instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide how long your treatment with Atorvastatin Krka should last.

Ask your doctor if you think that the effect of Atorvastatin Krka is too strong or too weak.

If you take more Atorvastatin Krka than you should

If you accidentally take too many Atorvastatin Krka tablets (more than your usual daily dose), consult your doctor or the nearest hospital, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Atorvastatin Krka

If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

If you stop taking Atorvastatin Krka

If you have any further questions about the use of this medicine or wish to discontinue treatment, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse effects or symptoms, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department straight away.

Rare (may affect up to 1 in 1,000 people):

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe breathing difficulties.
• Serious illness with severe skin peeling and inflammation; skin blisters, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which may develop into blisters.
• Muscle weakness, tenderness, pain, muscle breakdown, or change in urine colour to red-brown, and especially if occurring together with a feeling of malaise or high temperature, which may be due to abnormal muscle destruction (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin, and this can be fatal and cause kidney problems.

Very rare (may affect up to 1 in 10,000 people):

• If you experience problems with unexpected or unusual bleeding or bruising, this may indicate a liver problem. You should consult your doctor as soon as possible.
• Lupus-like illness syndrome (including skin rash, joint disorders, and effects on blood cells).

Other possible adverse effects with Atorvastatina Krka:

Frequent adverse effects (may affect up to 1 in 10 people) include:

• Nasal congestion, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you have diabetes, monitor your blood sugar levels), increased blood creatine kinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Blood test results showing abnormal liver function

Uncommon adverse effects (may affect up to 1 in 100 people) include:

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, changes in taste sensation, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing stomach pain)
• Hepatitis (inflammation of the liver)
• Rash, skin rash and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, feeling unwell, weakness, chest pain, swelling, especially in the ankles (oedema), increased temperature
• Positive urine tests for white blood cells

Rare adverse effects (may affect up to 1 in 1,000 people) include:

• Vision disturbances
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon injury
• Skin rash or mouth ulcers (drug-induced lichenoid reaction)
• Purple-coloured skin lesions (signs of blood vessel inflammation, vasculitis)

Very rare adverse effects (may affect up to 1 in 10,000 people) include:

• Allergic reaction – symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of the breasts in men)

Adverse effects with frequency not known (cannot be estimated from available data):

• Persistent muscle weakness.
• Myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing)
• Ocular myasthenia (a condition causing weakness in the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible side effects of some statins (medicines of the same type):

• Sexual difficulties
• Depression
• Respiratory problems such as persistent cough and/or difficulty breathing or fever
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, if you are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin Krka

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage temperature.

Store in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin Krka

• The active substance is atorvastatin. Each tablet contains 20 mg of atorvastatin as atorvastatin calcium.
• The other components (excipients) are: sodium hydroxide, sodium lauryl sulfate, hydroxypropyl cellulose, lactose monohydrate (see section 2 “Atorvastatin Krka contains lactose and sodium”), microcrystalline cellulose, sodium croscarmellose, crospovidone and magnesium stearate in the tablet core; and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc in the film coating.

What Atorvastatin Krka looks like and contents of the pack

Atorvastatin Krka 20 mg film-coated tablets are white, round (diameter = 8 mm), slightly convex, with bevelled edges.

It is available in cardboard boxes containing blisters with 10, 14, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For more information about this medicine, contact the local representative of the Marketing Authorisation Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Date of the most recent revision of this leaflet: January 2025

“Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”